Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult … (NCT02058784) | Clinical Trial Compass
CompletedEarly Phase 1
Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects
United States28 participantsStarted 2014-02
Plain-language summary
Open label study of Pracinostat will be tested to assess the effect of food on the single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted and fed conditions.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy, adult, male or female, 18-55 years of age, inclusive, at screening.
* Cohort 1 only: continuous nonsmoker who has not used nicotine-containing products for at least 6 months prior to the first dose and confirmed by urine cotinine test at screening.
* Cohort 2 only: moderate to heavy smokers defined as \> 1 pack of cigarettes per day or \> 39 cigarettes per week for at least 6 months prior to the first dose and confirmed by urine cotinine test at screening.
* Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI.
* For a female of non-childbearing potential:
* A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study medication. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to study start. A male who has been vasectomized less than 4 months prior to study start must follow the same restrictions as a non vasectomized male).
* Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol
Exclusion Criteria:
* Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the condu…
What they're measuring
1
Assess the effect of food on a single-dose PK of pracinostat in nonsmoking healthy adult subjects